Post approval services for pharmaceutical and biotech companies range from patient registries, Phase IV, Non interventional programs, pharmacovigilance etc. Services span to the entire life cycle of the drug post marketing with a keen focus on meeting challenges and addressing FDA/EMEA safety norms.
The need for more safe and reliable drugs has led to robust post approval pharmacovigilance, leading to pressure on both, pharmaceutical and biopharmaceutical world. PV services helps the management strategize and plan for post marketing FDA/MHRA/EMEA scrutinization. Post-marketing safety services include adverse event report case management (receipt, tracking, data entry, assessment, coding, and follow-up); electronic submission of individual case safety reports to regulatory authorities; literature review for reports of adverse events; aggregate reporting; and signal detection. Preparation of risk management plans, negotiation of risk management strategy with regulatory agencies, and execution of risk management strategies including Late Phase studies, Medical information submission and safety norm analysis.
To meet the strict regulatory requirements, along with managing the risk-benefit profile of products, and in order to maximise product potential, whilst ensuring patient safety safety data, clinical data, analysis and reporting is done diligently and some time it involves epidemiological data as well.
Post authorisation services include PV Consultancy and Project Management, Individual Case Safety Report (ICSR) Processing of Initial/Follow-up reports, MedDRA coding, Case Narratives, Pharmacovigilance Physician services, Global Expedited Case Reporting, EudraVigilance reporting using EVWEB, Safety Data Management & Global Safety Database - Oracle Argus, Signal Detection & Evaluation, Periodic Safety Update Report (PSUR) preparation and submission, Global Literature Search & Review, Local literature review, Pharmacovigilance Quality Assurance including SOP development, Pharmacovigilance Awareness Training, Safety Data Exchange Agreements (SDEAs) and reconciliation of ICSRs with partners, Risk Management Plan production, review and maintenance, Pharmacovigilance System Master File (PSMF), Company Core Safety Information (CCSI) production and maintenance, Regulatory Intelligence, Adverse Event Follow-up, Product Quality Complaints, Pre/Post-Marketing Clinical Studies, Development of Medical Information, Special Projects, Draft report preparation for PMDA (infectious diseases, researches, overseas safety measures) and SGML file generation, Draft DSUR preparation, PSURs/PBRERs and PADERs, COs and ACOs, etc.
Another key requirement of the EU legislation for PV studies is the stipulation that, without exception, a Qualified Person for Pharmacovigilance (QPPV) must be appointed to oversee the pharmacovigilance services for authorised products held by the company.
The regulatory updates in major CRO’s are maintained in an online system for real time access. This includes Competent Authority, Ethics Committee and Investigator safety set-up and expedited and periodic submission decisions for Clinical Trials, Post-Marketing, Medical Devices, In Vitro Diagnostics, along with scope for other areas.IT and surveillance related services for a robust PV study includes Implementation, validation, maintenance & upgrade of Argus applications, Design, development & submission of regulatory, operational, analytical & custom reports, Validated and up-to-date case processing platform in a secure environment, Signal evaluation/assessment and reporting, Meta-analysis of published safety data etc.
Natural history studies, Pragmatic trials, Disease/drug registries, Quality-of-life and patient-reported outcomes, Health outcomes/health economics, Comparative effectiveness studies, Real-world data for healthcare decision making are some of the studies/ questions which need to be answered during Life cycle management studies of a drug.
LCM studies include Method development, transfer and phase appropriate validation, Release and stability testing from preclinical phases through the commercial life of product, Monitoring and identification of data trends ? control charting & review, In process testing, Reference standard and critical reagent control and distribution, Active monitoring and reporting from proposal to invoice through a single point of contact, Project planning and key project milestones with dates of deliverables, Project scope definition and accuracy of the contract, Reference standard and critical reagent control and distribution, Communication of project updates, Monitoring of work scope changes and reconciliation of financials, Change in manufacturing site, addition/deletion, Optimization of manufacturing process, Change in formulation, Batch size change, Addition of new supplier for active substance, Inclusion of additional source for starting material for drug substance, Change in route of synthesis, Certification of Suitability (CEP) updates/new CEP, Change in equipment/instruments, Monograph updates i.e. Compliance to Pharmacopoeia, Analytical method changes, Changes in container closure system, Change in primary packaging material supplier and Shelf life extension/reduction.
Generics account for a significant percentage of the global small-molecule drug market today, and biosimilars are poised to make strong gains in the biopharmaceutical sector. Aggressive generics/biosimilar companies develop their products parallel to the innovator company and increasingly are introducing them before patent protections on branded counterparts have expired. Consequently, pharmaceutical product life cycle management (LCM) strategies can no longer focus solely on the period from launch to patent expiry. Successful drug manufacturers now include the entire lifecycle from discovery through end of life. Contract development and manufacturing organizations (CDMOs) with expertise in both the development and commercialization of new drug products and life cycle management strategies play a key role in supporting these much more extensive and complex LCM activities.